David Shoultz

When I started graduate school to study infectious disease epidemiology nearly 20 years ago, research and development (R&D) for neglected diseases was generally poorly funded, and there were very few promising new drug or vaccine candidates in the development pipeline.  While combination drug therapies for HIV were becoming available to patients in developed countries like the US, it would be years before these treatments would begin to be accessible to patients in countries where the epidemic was most intense.

Today BioVentures for Global Health estimates that there are now more than 87 new drug and vaccine candidates in the development pipeline for neglected diseases such as HIV, diarrheal diseases and malaria.   Taking into consideration new diagnostic tests that are being developed for diseases like tuberculosis (TB), human African trypanosomiasis (HAT), and lymphatic filiariasis (LF), we are at a watershed moment for global health – more than 100 credible product candidates under development for diseases that cause mortality, morbidity, and misery for billions of people around the world.

This is an incredible achievement and getting to this point has required a remarkable effort by a ‘cast of thousands’.

I was recently part of a working group at the Center for Global Development (CGD) in Washington, D.C. on improving clinical trials and regulatory pathways to fight neglected diseases.  In our report, we cite the role of product development partnerships (PDPs) such as PATH and the Medicines for Malaria Venture (MMV) as well as the Bill & Melinda Gates Foundation, the US National Institutes of Health and the Wellcome Trust.

As highlighted in the report, the development of a new product candidate typically requires an enormous commitment of resources – including reliable funding streams.

With this in mind, it’s worth considering the implications of the 2011 Global Funding of Innovation for Neglected Diseases (G-FINDER) report, which provides an overview of global research & development (R&D) funding provided for 31 neglected diseases in 134 product areas.   This year’s report paints a mixed picture: a small decrease in funding for neglected disease R&D and a drop of $47 million in funding for PDPs, but a 35 percent increase in the neglected disease R&D funding from pharmaceutical companies.

Of the $483 million invested in these product development partnerships in 2010, 94 percent was provided by just 12 funders.

Many of these partnerships have yielded impressive results.

Last December, a ground-breaking partnership consisting of the Meningitis Vaccine Project at PATH, the World Health Organization (WHO), the US FDA, Serum Institute of India, Synco BioParthers, and the Bill & Melinda Gates Foundation launched MenAfriVac™ – a vaccine against meningitis A specifically designed for the African communities in the ‘meningitis belt‘ and available at 50 cents (US) per dose.

Nearly 20 million people were vaccinated in the first two months following the life-saving vaccine’s launch.

New sources of funding are essential to sustain this type of catalytic partnerships.

On the financing front, the Bill & Melinda Gates Foundation continues to explore innovative financing approaches to support product development, including guaranties, loans, equity investments, and investment funds.

We’re far from alone in the work and learning that we’re pursuing in this area. In an excellent review of the topic, Robert Hecht and his colleagues describe a menu of ‘push’ and ‘pull’ mechanisms for R&D, including tax credits, market guarantees, purchase funds, prizes, intellectual property incentives, and patent buyouts.

Mechanisms such as the Priority Review Voucher program at the US FDA may provide the extra incentive that pharmaceutical companies need to prioritize R&D for neglected diseases. New participants (including venture capital and private equity firms, banks, and sovereign wealth funds) are needed in this space – as sources of capital, creativity, and financial expertise.

Governmental and conventional philanthropic funding sources are necessary but not sufficient for sustaining neglected disease R&D.  New partnerships and innovative approaches to finance neglected disease R&D are critical for continuing to build on our successes to date.

It’s an incredibly exciting challenge.

David Shoultz is a deputy director for the infectious diseases division of the Global Health Program at the Bill and Melinda Gates Foundation

This article was first published on the Gates Foundation blog, http://www.impatientoptimists.org/